Heba K.

 Preparing New/ Renewal/ Variation registration files for Exportation according to guidelines of the NMPB  Technical reviewing of data & Preparing Modules I, II, III, V according to CTD format , NeeS & Soft Copy of CTD Modules for our Agent to be submitted in e-CTD program.  Fulfill Regional information documents (e.g. Cover letter, Application Form, Official Declaration Letters).  Follow-Up with different departments to fulfill all registration requirements.  Keeping up-to-date with changes in regulatory legislation and guideline’s.  Handling any Inquiry or deficiency letter.  Preparing deficiency response in a clear presentation to the authority.  Requesting different registration certificates from MOH (e.g. CPP, Pricing & GMP) & follow-up with Egyptian MOH (exportation department) until issued.  Provide Suitable advice to our different departments for any received inquiry according to my experience as regulatory.  Follow –up & contact with our different agents for contracting & registration of our products.  Make a database & preparing periodical reports for Status of our products

- Ensure appropriate and necessary labeling to meet regulatory requirements, with focus on sustaining products. - Assist in the development of solutions for labeling projects, involving country-specific requirements in collaboration with business units. - Technical Editor for activities that establish labeling content ; including evaluating information input into system to determine necessary content for use in labeling. Follow and maintain timetables for creating new/revised content and labeling in a cost-effective manner Participate in process improvement projects and SOPs Other incidental duties, including the rest of regulatory activities at the Egyptian MOH.

Leading a team, handling and coordinating the ongoing regulatory affairs services that are targeting the GCC pharmaceutical and healthcare market. Main responsibilities: - Coordinating and handling a variety of healthcare and cosmetics products registration within the GCC market - Liaising with and following-up on the GCC health authorities, as well as linking with client companies and the health authorities - Advising on products' labels and artwork specifications and design - Handling sites registration and licensing - Building a corrective action plan and advising client companies on CAPA and GMP inspections - Compiling and submitting critical technical documents and DMF (CTD, eCTD, NeeS..etc) - Advising on the compliance of clients' products formulations according to the GCC requirements - Product development and developing OTC drugs, supplements and fortified foods formulations - Spreading circulations to the stakeholders to update on the GCC new regulations

Applying combined knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of companies, meet the required legislation in the GCC market. - Ensuring that a company's products comply with the regulations of the SFDA; - Keeping up to date with international legislation, guidelines and customer practices in the GCC; - Collecting, collating and evaluating scientific data that has been submitted by clients; - Preparation of technical documents (i.e. CTD, eCTD, NeeS); - Writing clear, accessible product labels and patient information leaflets; - Advising scientists and manufacturers on regulatory requirements; - Providing strategic advice to senior management throughout the development of our regulatory services; - Reviewing company practices and providing advice on changes to systems; - liaising and communicating with the regulatory authorities; - Specifying storage, labeling and packaging requirements.